Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes (RECORD): A multicentre, randomised, open-label trial
Home PD et al. – Addition of rosiglitazone to glucose-lowering therapy in type 2 diabetes pts is confirmed to increase the risk of heart failure and of some fractures, mainly in women. Data are inconclusive for effects on myocardial infarction; howver, rosiglitazone does not increase risk of overall cardiovascular morbidity or mortality vs standard glucose-lowering drugs. Methods- Study of cardiovascular outcomes after rosiglitazone addition to either metformin or sulfonylurea vs combination of the 2 over 5-7-yr follow-up
- Comparative safety assessment
- Multi-center, open-label trial of 4447 type 2 diabetes pts on metformin or sulfonylurea monotherapy with mean hemoglobin A1c (HbA1c) of 7.9%
- Randomization to addition of rosiglitazone (2220 pts) or combination of metformin and sulfonylurea (active control group, 2227)
- Primary endpoint: cardiovascular hospitalization or cardiovascular death
Results- During mean 5.5-yr follow-up, primary outcome met by 321 rosiglitazone pts and 323 active controls, meeting non-inferiority criterion
- Heart failure causing admission to hospital or death in 61 people in rosiglitazone group and 29 in active control group
- Upper and distal lower limb fracture rates increased mainly in female rosiglitazone pts
- Mean HbA1c lower in rosiglitazone vs control group at 5 yrs
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